Lifestyle Modification Program for Lung Cancer Patients - A Pilot Study

Not Applicable

• Conditions: Cancer, Lung
• Interventions: Behavioral: Lifestyle-integrated exercise; Behavioral: Healthy living information

• Registration Number: NCT04105647
• Lead Sponsor: The University of Hong Kong

Brief Summary

Lung cancer is one of the most common cancer diseases, globally and locally. Several health benefits of increased physical activity (PA) have been reported for people with cancer. PA plays a critical role across the cancer trajectory, from prevention through to post-diagnosis and has been proposed as an alternative for improving physical and psychosocial health outcomes, reducing cancer recurrence, and cancer-specific and all-cause mortality.

Although there are a variety of exercise intervention programs for cancer patients, those programs were quite intensive, requiring individuals to commit extra time and effort. Feeling of overwhelmed appointments, lack of time, other barriers, including high cost and limited access to facilities are the most frequently reported barriers that prevent people from starting and maintaining exercise. Hence, the investigators propose to use a brief messaging lifestyle modification intervention program to incorporating simple and easy-to-do patient-centred home-based lifestyle-integrated exercise into daily activities of patients with lung cancer. The aims are to increase patients' physical activity and improve their fatigue, emotion and quality of life, compared to the control group.

Detailed Description

Lung cancer is one of the most common cancer, globally and locally. Patients with lung cancer are in a uniquely challenging situation in their disease, comorbidities, and treatment that may lead to worsened symptoms and many negative health consequences, including fatigue, irritability, and impaired daytime functioning.

Physical activity (PA) is defined as 'any bodily movement produced by skeletal muscle that results in energy expenditure'. Several health benefits of increased PA have been reported for people with cancer. PA plays a critical role across the cancer trajectory, from prevention through to post-diagnosis and has been proposed as an alternative for improving physical and psychosocial health outcomes, reducing cancer recurrence, and cancer-specific and all-cause mortality. Although there are a variety of exercise intervention programs for cancer patients, those programs were quite intensive, requiring individuals to commit extra time and effort. Most clinicians underutilise exercise therapy, regardless of its low-cost way to improve symptoms and potential health outcomes. Feeling of overwhelmed appointments, lack of time, other barriers, including high cost and limited access to facilities are the most frequently reported barriers that prevent people from starting and maintaining exercise. Low motivation, fear to exercise, lack of knowledge about benefits are the most common barriers of engaging in physical activity for cancer patients.

Hence, the current proposal is to use a brief messaging lifestyle modification intervention program to incorporating simple and easy-to-do patient-centred home-based lifestyle-integrated exercise (light to moderate physical activity) into daily activities of patients with lung cancer.

The investigators hypothesised that patients in the experimental group would display significantly higher increases in physical activity and improvements in fatigue, emotion and quality of life, compared to the control group.

The objectives are to examine the short-term clinical effects on impacts on fatigue, emotion and quality of life in patients with lung cancer, and to evaluate the feasibility of a brief lifestyle-integrated exercise program to increase physical activity by a pilot study with objective fitness and subjective questionnaire assessment, and focus group interviews.

Study Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-26
• Study Start: 2019-10-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-25
• Last Update Posted: 2020-04-28
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Aged 18 years and above;
• Diagnosis with non-small cell lung cancer
• General condition stable, either is undergoing or finished treatment
• Able to speak and read Chinese
• Able to complete the self-administered questionnaire
• Able to use instant messages such as WhatsApp or WeChat
• Mental, cognitive and physically fit determined by the clinicians/investigators
• Signed informed consent

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Exclusion Criteria

• Pre-operative lung cancer
• Skeletal fragility
• Serious active infection
• Inability to walk
• Previously untreated symptomatic brain metastases
• Severe respiratory insufficiency
• Uncontrolled pain

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Lifestyle-integrated exercise	Patients in the experimental group will receive a face-to-face group session and a package of healthy lifestyle instant messages, including lifestyle-integrated exercise and physical activity.
Control group	Healthy living information	The control group will receive a face-to-face group session and a package of healthy lifestyle instant messages, but not related to lifestyle-integrated exercise and physical activity.

Primary Outcome Measures

Name	Time	Method
Change in fatigue level at 6 weeks	Baseline and 6 weeks	measured by Brief Fatigue Inventory

Secondary Outcome Measures

Name	Time	Method
Change in activity level at 6 weeks	Baseline and 6 weeks	measured by fitbits
Change in health-related quality of life at 6 weeks	Baseline and 6 weeks	measured by European Organisation for Research and Treatment of Cancer and lung module questionnaire
Change in excessive daytime sleepiness at 6 weeks	Baseline and 6 weeks	measured by Epworth Sleepiness Scale. It is a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a score ranged from 0 to 24. The higher score the more sleepiness.
Change in physical activity at 6 weeks	Baseline and 6 weeks	measured by International Physical Assessment Questionnaire - Short version
Change in insomnia level at 6 weeks	Baseline and 6 weeks	measured by Insomnia Severity Index
Change in balance at 6 weeks	Baseline and 6 weeks	assessed by a single-leg-stance test by recording the time within which the individual could effectively achieve balance on one leg
Change in flexibility at 6 weeks	Baseline and 6 weeks	assessed by chair sit and reach test
Change in endurance at 6 weeks	Baseline and 6 weeks	assessed by 6-minute walk
Change in functional level at 6 weeks	Baseline and 6 weeks	measured by Functional Assessment Cancer Therapy - Lung (FACT-L) questionnaire
Change in anxiety and depression symptoms at 6 weeks	Baseline and 6 weeks	measured by Hospital Anxiety and Depression Scale. Each item is answered on a 4-point scale (0-3). The scores for the seven questions on depression are added together to obtain a score ranged from 0 to 21. The higher score the more depressed. The scores for the seven questions on anxiety are added together to obtain a score ranged from 0 to 21. The higher score the more anxiety.
Change in sleep quality at 6 weeks	Baseline and 6 weeks	measured by Pittsburgh Sleep Quality Index
Change in hand grips strength at 6 weeks	Baseline and 6 weeks	measured by a dynamometer
Change in lower limb strength at 6 weeks	Baseline and 6 weeks	assessed by using a 30-second chair stand test to record the number of stands from chair in 30 seconds

Trial Locations

Locations (2)

Agnes; 🇭🇰 Hong Kong, Hong Kong

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong